Kimara Tablets 20 mg (Leflunomide)

Adult dose

1. Loading dose Given the long half-life of this drug and the recommended dosing interval of 24 hours, treatment is generally started with a loading dose to reach steady-state plasma concentrations more quickly. Administer 100mg once daily for 3 days as the loading dose. In patients with rheumatoid arthritis, omitting the loading dose may reduce the risk of adverse reactions (see section ‘5. General Precautions 9)’). 2. Maintenance dose Administer 20mg once daily as the maintenance dose for patients with rheumatoid arthritis. When 25mg once daily was administered, some patients experienced adverse reactions such as hair loss, weight loss, and elevated liver enzyme levels. Therefore, the maintenance dose should not exceed 20mg once daily. If the patient’s clinical tolerability is poor, the maintenance dose may be reduced to 10mg once daily. Administer 20mg once daily as the maintenance dose for patients with psoriatic arthritis. Monitor liver enzyme levels; dosage adjustment may be necessary. (See Warnings—Hepatotoxicity.) Because the half-life of the active metabolite of this drug is prolonged, it may take several weeks for the metabolite concentration to decrease. Therefore, monitor patients carefully after reducing the dose.

This drug remains in the body for a long time and side effects may persist even after discontinuation. If serious side effects occur, special medications must be administered to rapidly remove this drug from the body. It can affect liver function, so patients with liver disease or impaired liver function must confirm their liver status before use. In particular, liver function tests should be conducted monthly during the initial six months of treatment, and thereafter at intervals of 6 to 8 weeks. Extra caution is required when used in conjunction with other hepatotoxic medications or in patients with a history of liver disease. This drug can suppress the immune system, and it is advisable not to use it in patients with serious infections or immunodeficiencies. Patients with lung issues or a history of pneumonia should confirm their condition through chest X-ray before treatment and use with caution. Severe allergic reactions on the skin, ulcers, or wound healing disturbances may occur; therefore, treatment should be discontinued immediately in case of abnormal symptoms. Women who are pregnant or may become pregnant should not take this drug, as it may pose risks to the fetus. This medication contains lactose, so patients with lactose intolerance should not use it. Regular blood tests should be performed to monitor white blood cell and platelet counts; if abnormalities are detected, consult a doctor immediately. If symptoms of infection such as fever, cough, or difficulty breathing appear during treatment, visit a hospital promptly. There may be interactions with other drugs, so it is essential to inform the doctor about any medications currently being taken, especially regarding hepatotoxic drugs, immunosuppressants, and anticoagulants. Overdose may result in diarrhea, abdominal pain, and blood abnormalities, and special detoxification treatment may be required in such cases. Store protected from direct sunlight, ideally at a temperature below 25 degrees Celsius. This drug is not recommended for children under 18 years of age, and it can be used by seniors over 65 years without dose adjustment. During treatment, regular monitoring of blood pressure, liver, and blood status is necessary. This drug affects the immune system, so special attention must be paid to infection prevention, and vaccination with live vaccines should be avoided.

• Diarrhea
• increased liver enzyme levels (ALT, AST)
• hair loss
• rash
• hypersensitivity reactions
• weakness
• flu-like syndrome
• upper respiratory infection
• injury
• pain

This drug is sensitive to light, so it should be stored away from direct sunlight. Additionally, it is important to store it in a closed container to prevent contact with air. The storage temperature should be maintained in a cool place below 25 degrees Celsius.

Appearance

Light yellow triangular film-coated tablet

Package unit

30 tablets per bottle